August 2009 Archives

The FDA has issued a new safety warning for the NNRTI Intelence (etravirine). The text reads:

 

August 2009
Dear Healthcare Professional:
 
Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, would like to inform you of an important safety update to the Severe Skin Reactions WARNINGS AND PRECAUTIONS section (5.1) of the INTELENCE (etravirine) tablets prescribing information.
 
Specifically, the existing Warning and Precaution regarding Severe Skin Reactions has been strengthened to reflect that there have been postmarketing reports of:
• fatality due to toxic epidermal necrolysis
• hypersensitivity reactions, sometimes accompanied by hepatic failure
Additionally, Guidance has been added that INTELENCE should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop. Given the clinical relevance of these adverse reactions, the following information regarding severe skin and hypersensitivity reactions has been included in the INTELENCE Prescribing Information

 

These kinds of reactions have been seen with other drugs in this class. 

 

Intelence (aka worst HIV drug name ever) is a second line NNRTI for use in people whose HIV has developed resistance to other NNRTIs, like Sustiva (efavirenz) and Viramune (niravapine). 

The New York Times has an article today on the possibility the CDC might recommend routine male circumcision in the US to prevent HIV infection. Both sides in this argument fail to make their case.

Male circumcision is an effective prevention method- in areas with high seropravelence (lots of people with HIV) and high rates of heterosexual sex transmission. Data of this began emerging around a decade ago, and eventually randomized trials showed it to be effective.

So, if it has been show to work, why not do it here? Because there is little reason to think it would work.

To begin with, the US is not a high seroprevalence country. Nor do we have high rate of heterosexual sex transmission. And around 70% of boys already are circumcised.

The studies on male circumcision have looked exclusively at its effect on heterosexual transmission in areas of high seroprevalence. Extrapolating their findings to the US doesn't make much sense.

The opponents of circumcision don't manage to make much of a case themselves. They have rented mobile billboards to cruise around Atlanta during the ongoing HIV Prevention conference, simply saying- Circumcising Babies Doesn't Stop H.I.V." A spokes-person is quoted as saying that the studies done in Africa only found that circumcision reduced HIV infection risk, and that 'Men still need to use condoms.'

Sigh.

No prevention method is perfect- none works all the time. That is, simply put, irrelevant.

I honestly don't know where this debate will go. The prevention world is riddled with flimsy science and even flimsier extrapolation from that science. I am in favor of increased exploration of novel HIV prevention modalities, particularly biomedical ones. I think we have long since hit a wall on our behavioral interventions (not that they should be abandoned, but we are past the point of diminishing returns). As with questions of treatment, these examinaitons should be driven by good, solid science.If this is any indication- I am not hopeful.  

In addition to being an AIDS activist, I am an anarchist. I have been mixed up in radical and revolutionary activism since I was a teenager, attending anti-nuclear demonstrations at the Seneca Army Depot in upstate New York.

The worlds of AIDS activism and anarchist activism don't overlap much (Liz, this is me winking at you, if you read this), but they do act a lot alike.

Recently there was a dust up between two groups of anarchists in Pittsburgh. It happened at this meeting called by a group called Crimethinc- who I really have no love for. The short version of the story is a small group of anarchist people of color disrupted the larger gathering and used intimidation and petty thuggery to force the attendees to leave the space.

I wasn't at the meeting, so I can't speak in any real detail about what went down. I have read pages upon pages of accounts from people on both sides of the controversy- and I think it is fair to say the whole thing is an embarrassment.

It is also highly evocative of the AIDS activist movement. Specifically it speaks to a tendency to attack each other while simultaneously wondering why there aren't more of us.

Every activist strain I have been involved in has struggled with the impact that racial, sexual and other forms of inequality have on the internal dynamics of the movement. AIDS activism in the US is disproportionately white, educated and male- something we are aware of, we talk all the time about, we seriously grapple with how to change, and ultimately fail to overcome.

Social conditioning is tough to overcome. What doesn't help matters I think is our tendency to attack those who we feel are not as right as us. In the anarchist world this often translates to people being called out for not behaving in ways entirely consistent with their politics (e.g. feminist men dominating meetings). In AIDS it takes on a more personal aspect, possibly because there are so few of us.

 

In both cases the net affect is a movement that can't grow. AIDS activists struggle to find ways of nurturing and helping to develop young, or just new cadre. It is complicated stuff. Years ago at the now-defunct NATAF (North American Treatment Action Forum), I overheard a woman say, "Treatment activist eat their young," What she meant was we are viscous and harsh with each other. At the same conference I heard and participated in many conversations lamenting the lack of new activists in our mix.

Activists are often playing from a sever deficit. We are usually outmanned, outgunned, outflanked and out-funded. This is as true of AIDS activism as it is for anarchists. Our adversaries hold most of the cards. We would do well to better recognize the value of imperfect bodies on our side.

This story from CNN.com announces the discovery of a new strain of HIV. Briefly, scientists have identified a 4^th major type of HIV-1, this one originating from gorillas, unlike the previously identified strains that came from chimpanzees.

What does this mean? Likely not much, but it warrants keeping an eye on.

This discovery will likely be mostly of interest to few. It isn't likely to change the epidemic in any meaningful way- and if it does, it would take years and years before that became true.

It interests me because it deepens our understanding of the origin of HIV. Where HIV came from, how and when it jumped to humans and how it grew to a world wide pandemic are fascinating questions.

Many people favor conspiratorial approaches to understanding complex questions, I favor natural explanations. In the HIV world, we are beset by a group of flat-earthers who believe that HIV was cooked up in a lab by evil government or pharmaceutical or illuminati agents. This world view is not restricted to HIV- apparently as the Swine Flu epidemic is hitting Argentina quite hard, various forms of denialism are rearing their cretinous heads- saying either the virus was engineered by big Pharma, or by the vaccine makers, or as a social control mechanism- or all of the above.

To me this is anthropocentric hubris- the fatally flawed belief that humans are the center of the world. We are certainly special creatures- capable of much. But our influence is much more limited than we tend to think. The microbial world is more complex, varied and impactful than any of us can likely imagine. I like to point out to people that our bodies have 10 times as many microbial cells than human cells. Our planet is not really ours- we are just bit players in a much bigger, more interesting story.

I don't choose to see 'nature' or 'the earth' in human-centric terms (mother earth, gia, father sun...). We are of nature, it is not of us. I am certain that humans are capable of the kind of evil that would brew up a deadly virus and seek to use it to harm whole populations. I am also certain that viruses have been morphing long before human avarice was a sly glint in a troglodyte's eye. Again with Occam's Razor- the simplest explanation is most often the correct one.

So, we have another strain of HIV to study. And study it we will.